comparison between ilux™ and lipiflow® in the treatment of meibomian gland dysfunction

Conditions: Meibomian Gland Dysfunction

Summary: the purpose of this study was to compare changes in meibomian gland dysfunction (mgd), tear break-up time (tbt) and evaporative dry eye (ede) symptoms after treatment with either the ilux® 2020 system or the lipiflow® thermal pulsation system.

at the baseline visit (day 0), subjects were assessed pre-treatment, during treatment, and post-treatment.

Eligibility criteria:
inclusion criteria: * age 18 years and older of any gender or race * written informed consent to participate in the study * willingness and ability to return for all study visits * positive history of self-reported dry eye symptoms for three months prior to the study using osdi with a score of ≥ 23 at the baseline visit * evidence of meibomian gland (mg) obstruction, based on total mgs of ≤12 in lower eyelids for each eye as assessed by a clinician not involved in the study procedure * tear break-up time \<10 seconds * agreement/ability to abstain from dry eye/mgd medications for the time between the screening visit and the final study visit (ocular lubricants are allowed if no changes are made during the study) exclusion criteria: * history of ocular or corneal surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year * subjects with giant papillary conjunctivitis * subject with punctal plugs or who have had punctal cautery * ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination * active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months * subjects who are aphakic * cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc. * active ocular infection * active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months * ocular surface abnormality that may compromise corneal integrity * lid surface abnormalities that affect lid function in either eye * anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4) * systemic disease conditions that cause dry eye * unwillingness to abstain from systemic medications known to cause dryness for the study duration * women who are pregnant, nursing, or not utilizing adequate birth control measures * individuals who have either changed the dosing of systemic medications or non-dry eye/mgd ophthalmic medications within the past 30 days prior to screening * individuals who are unable or unwilling to remain on a stable dosing regimen for the duration of the study * individuals using isotretinoin (accutane) within 1 year, cyclosporine-a (restasis) or lifitegrast ophthalmic solution 5% (xiidra) within 3 months, or any other dry eye or mgd medications within 2 weeks of screening (ocular lubricants are allowed if no changes are made during the study) * individuals wearing contact lenses at any time during the prior three months or during the study period * eyelid tattoos, including permanent eyeliner makeup * individuals that were treated with lipiflow in either eye in the last 24 months * individuals using another ophthalmic investigational device or agent within 30 days of study participation * individuals who are unable to complete the required patient questionnaires in english

Keywords: ilux lipiflow dry eye meibomian gland dysfunction evaporative dry eye